BFS Single-dose Ampoule Filling Line (Integrated Aseptic Blow-fill-seal System)

BFS single-dose ampoules: container characteristics

A safe and controlled single-dose format

BFS (Blow-Fill-Seal) single-dose ampoules are made from pharmaceutical-grade LDPE, a material recognised for its safety and compatibility with sensitive formulations. They are available in volumes ranging from 0.2 ml to 10 ml, suitable for the requirements of sterile single-dose products.

A fully aseptic BFS process

Thanks to the Blow-Fill-Seal system, forming, filling and sealing are carried out continuously in an aseptic area. The twist-off cap, integrated directly into the ampoule moulding, ensures easy opening and perfect product integrity.

Suitable applications and uses

This format is particularly suitable for:

• injectable diluents,
• inhalation solutions,
• saline solution,
• formulations intended for nebulisation,
• paediatric products, thanks to their low particle content.

Point to note

BFS ampoules have a more limited gas barrier than glass, which should be taken into account for formulations that are highly sensitive to oxygen.

The BFS line according to EREA Pharma

Complete management of the Blow-Fill-Seal process

EREA Pharma develops lines that integrate the entire BFS process:

• extrusion of pharmaceutical LDPE,
• ampoule forming,
• precise volume dosing,
• twist-off sealing,
• direct control in an aseptic environment.

Each step is designed to guarantee microbiological safety, repeatability and compliance with regulatory requirements.

A line that can be adapted to the needs of each product

EREA designs facilities that can be adapted to:

• the target unit volume,
• the viscosity of the product,
• sterility requirements,
• the selected single-dose ampoule formats,
• the rates required for ramping up production.

A fully customised BFS filling line

EREA Pharma designs BFS filling lines that are designed to integrate seamlessly into any production environment. The company draws on its solid expertise in design, aseptic engineering and automation to offer truly customised equipment capable of meeting the technical and regulatory requirements specific to each product.

EREA’s teams support each customer at every stage of the project, from needs analysis to commissioning, including process qualification and optimisation. This tailor-made approach guarantees a reliable, reproducible production line that is adapted to the requirements of sterile single-dose solutions.

With this comprehensive mastery of the BFS process, EREA Pharma offers a complete tool for producing compliant, safe single-dose ampoules that are ready for integration into the most demanding pharmaceutical applications.